Phase 3 Clinical Trial to Be Conducted This Year
Daewoong Pharmaceutical announced the results of a phase 2 clinical trial of SGLT-2 diabetes treatment Enavogliflozin at the 2020 International Conference on Diabetes and Metabolism (ICDM) which was held from Sept. 18-19.
The ICDM was hosted by the Korean Diabetes Association. It marked its 10th anniversary and was held online due to COVID-19.
Enavogliflozin showed a statistically significant decrease in changes in glycated hemoglobin (HbA1c) from the fourth week of a 12-week administration of the drug to type 2 diabetics whose blood sugar was not properly controlled. In the 12th week, it decreased by about 0.9% compared to placebo. This is statistically significant and is an additional 0.2 to 0.3 percent reduction in glycated hemoglobin compared to other third-party SGLT2 inhibitors used on Westerners. The results make further research promising.
In the 12 weeks when Enavogliflozin’s treatment effects on subjects were evaluated, 61 percent of patients saw their glycated hemoglobin reach 7.0 percent or less, showing an increase of more than 20 percent in the proportion of patients who showed more positive effects compared to current SGLT-2 inhibitors. Up to 72 percent of patients with a decrease of 0.5 percent in their glycated hemoglobin compared to the baseline, showed Enavogliflozin’s excellent blood sugar reduction effects.
In addition, only two percent of those who took Enavogliflozin showed genital and urinary tract infections which are side effects that may occur due to the mechanism of the SGLT-2 inhibitor family, proving the drug’s strong safety. The percentage is significantly lower than 5 to 10 percent of those who took SGLT-2 inhibitors.
"We have confirmed Enavogliflozin’s effects and safety in lowering blood sugar through the clinical research comparing it with a placebo by administering Enavogliflozin only to more than 200 Koreans for 12 or more weeks," said Park Kyung-soo, a professor of internal medicine at Seoul National University Hospital and a clinical trial coordinator
Meanwhile, Daewoong Pharmaceutical is planning to complete the current phase 2 clinical trial of type 2 diabetes drug Enavogliflozin in Korea and begin a phase 3 clinical trial to obtain indication for the use of the drug in the treatment of type 2 diabetes by the end of 2020. The company aims to release the drug in Korea in 2023.